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Wednesday, October 27, 2021

Pfizer, BioNTech ask US regulators to approve Covid vaccine for kids ages 5-11

The FDA has set a date of Oct. 26 for outside advisers to meet and discuss the Pfizer application, making it possible for kids to begin receiving the vaccines shortly afterwards.

By: Reuters | Washington |
Updated: October 7, 2021 7:27:11 pm
A 12-year-old boy receives the first dose of a Covid-19 vaccine in New York. (AP)

Pfizer Inc and BioNTech have asked US regulators to approve emergency use of their Covid-19 vaccine for children aged five to 11, Pfizer said in a tweet on Thursday.

The application to the US Food and Drug Administration comes as Covid-19 infections have soared in children, hitting their highest point in the pandemic in early September, according to data from the American Academy of Pediatrics.

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The FDA has set a date of Oct. 26 for outside advisers to meet and discuss the Pfizer application, making it possible for kids to begin receiving the vaccines shortly afterwards.

A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.

 

The Pfizer-BioNTech vaccine was authorized in kids aged 12-15 roughly a month after the companies filed for authorization.

The vaccine, which is already authorized in 12 to 15-year-olds and fully approved for ages 16 and up, has been shown to induce a strong immune response in the target age group in a 2,268 participant clinical trial, the companies said on Sept. 20.

The Pfizer-BioNTech vaccine was authorized in kids aged 12-15 roughly a month after the companies filed for authorization.

While kids are less susceptible to severe Covid-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness.

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